Document Control Specialist
123 Main Street Berwyn, PA 19312
McGrath Systems is accepting applications for a Document Control Specialist for a DIRECT HIRE opportunity in the Berwyn, PA area.
- The Document Control Specialist is the EDMS SME, responsible for managing all aspects of the document control process from document creation, through collaboration, approval, release, and ultimately to retirement:
- Serves as the Master Control System Administrator SME and provides training/guidance to system end-users as needed, and in instructor-led settings
- Systematizes and streamlines document work flows; maintains training materials for the various levels of system users
- Prioritizes Change Control activities and drives Change Notices to completion using metrics and periodic reporting; Compiles process metrics, identifies trends and escalates accordingly
- Manages the release and control of updates to policies, procedures, instructions, etc.
- Manages Quality records and programs including: Vendor Management and Approved Supplier List, Organization Chart, GMP Signature Logbook, Environmental Monitoring, electronic and off-site document archiving
- Communicates effectively with cross-functional and external stakeholders on matters related to documentation systems
- Manages the inter-company Change Control/ECN process
- Assists in third-party ISO and GMP audits
- Implements best practice solutions to improve and maintain the QMS documents and CN process
Education and Experience:
- Associate Degree and a minimum of 3-5 years of hands-on work experience in QA Document Control in a regulated (GMP, ISO) environment; An equivalent combination of education, training and experience may substitute.
- Advanced/expert user of Microsoft Office Suite, Master Control, Adobe, SharePoint and computer skills in general. Master Control document system experience is essential
- Highly organized, detail oriented with solid analytical and technical writing skills; ability to detect potential problems and recommend potential solutions
- Strong verbal and written communication skills with the ability to work across functions and departments
For immediate consideration email resume to firstname.lastname@example.org or call 215-278-8746
McGrath Systems is an Equal Opportunity Employer and embraces diversity in the workplace.